Amgen
Biotech company creating biologic medicines
Manufacturing Specialist - Multiple Teams
About the job
- A doctorate degree and 2 years of biotechnology operations experience, or a master's degree in Engineering, Biology, Chemistry, Biochemistry, or a related field and 4 years of biotechnology operations experience, or a bachelor's degree and 6 years of biotechnology operations experience, or an associate's degree and 10 years of biotechnology operations experience, or a high school diploma/GED and 12 years of biotechnology operations experience.
- Technical expertise in Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services involving Raw Material Dispensing and Solution Preparation.
- Strong technical knowledge of drug substance manufacturing processes, equipment, and unit operations.
- Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment.
- Experience supporting manufacturing floor operations, troubleshooting, and hypercare activities.
- Experience supporting operational readiness activities including water runs, dry runs, equipment testing, and startup support.
- Experience authoring and maintaining GMP documentation, including SOPs and manufacturing procedures.
- Experience supporting manufacturing change controls and implementation activities.
- Experience participating in risk assessments, root cause analyses, investigations, and CAPA implementation activities.
- Experience supporting CAPA applicability assessments and effectiveness checks.
- Experience supporting Manufacturing Execution Systems and Electronic Batch Records within a GMP manufacturing environment.
- Knowledge of single-use technologies and Bill of Material structures.
- Technical writing, communication, problem-solving, and organizational skills.
- Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.
- Provide manufacturing floor support, troubleshooting assistance, and hypercare during routine manufacturing operations, process changes, startup activities, and first-time executions.
- Support operational readiness activities, including water runs, dry runs, equipment readiness verification, and Electronic Batch Record testing support.
- Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.
- Monitor process performance and identify opportunities for process optimization, operational improvement, and risk reduction.
- Support manufacturing-related change controls associated with process, equipment, procedural, and operational improvements.
- Author, revise, review, and maintain manufacturing SOPs, forms, and other GMP documentation.
- Ensure manufacturing processes are translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.
- Provide technical input to manufacturing risk assessments and support identification and mitigation of process, equipment, procedural, and operational risks.
- Participate in root cause analysis activities and provide technical process expertise to support manufacturing investigations, major deviations, and quality events.
- Support CAPA applicability assessments, CAPA implementation activities, and CAPA effectiveness checks.
- Partner with Process Development to support process overviews, knowledge transfer activities, and facility fit assessments.
- Partner with Supply Chain, Manufacturing, and Engineering to support material readiness and Bill of Material alignment, including single-use assemblies and consumables.
- Support Manufacturing Execution System and Electronic Batch Record activities by providing process expertise and manufacturing representation.
- Participate in inspection-readiness activities and support audits as required.
- Escalate process, operational, quality, and compliance concerns appropriately.
About the company
Amgen develops medicines that treat serious illnesses by using biologic therapies made from living cells. These therapies are designed to target specific disease processes, such as cancer, cardiovascular disease, and autoimmune conditions, and are produced through biotechnology methods that create proteins or antibodies. Amgen’s products are sold to patients and healthcare providers worldwide, with revenue funding ongoing research and development to discover new treatments. The company stands out by focusing on biologic medicines at a large scale and maintaining a steady pipeline of potential therapies across multiple disease areas, supported by global manufacturing and a commitment to bringing therapies to patients. Its goal is to improve patient outcomes by discovering and delivering new, effective treatments while reinvesting a significant portion of earnings into research and development.
Company Size
10,001+
Company Stage
IPO
Headquarters
Thousand Oaks, California
Founded
1980
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Simplify's Take
What believers are saying
- Amgen raised 2026 revenue guidance to $38.2 billion-$39.4 billion after Q2 outperformance.
- Repatha sales jumped 37% to $953 million, driven by cardiologist and primary-care adoption.
- MariTide now has nine ongoing and three planned Phase 3 studies across obesity.
What critics are saying
- Prolia and XGEVA sales fell 33% in Q2 2026 as biosimilars hit.
- FDA proposed withdrawing TAVNEOS in April 2026, threatening a marketed rare-disease franchise.
- If MariTide misses 2027 endpoints, Amgen loses its next obesity growth pillar.
What makes Amgen unique
- Amgen's six growth drivers produced nearly 70% of Q2 2026 product sales.
- IMDELLTRA sales rose 115% in Q2 2026, validating Amgen's oncology engine.
- Hyderabad's 2027 Science and Innovation Center expands Amgen's seven-lab global R&D network.
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Benefits
Professional Development Budget
Conference Attendance Budget
Company News
Revolution Medicines received FDA approval for daraxonrasib, the first targeted therapy for metastatic pancreatic cancer, after clinical data showed it reduced death risk by more than half. The company is clinical-stage with no current revenue and posted a $1.1 billion net loss in FY 2025. Amgen reported FY 2025 revenue of $36.7 billion, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. Free cash flow reached $8.1 billion. The company carries a debt-to-equity ratio of 6.3x. Revolution Medicines maintains a 0.1x debt-to-equity ratio and 9.5x current ratio but recorded negative free cash flow of $913.7 million. The company's pipeline targets RAS-driven tumours including lung cancer. A partnership with Royalty Pharma provides funding for development. Both companies face distinct risks: Amgen confronts pricing pressures and biosimilar competition, whilst Revolution Medicines carries clinical trial failure risks and competes against larger pharmaceutical firms.
Amgen reported revenue of $36.7 billion in FY 2025, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. The biotech giant maintains a debt-to-equity ratio of 6.3x and generated $8.1 billion in free cash flow. CRISPR Therapeutics, meanwhile, saw revenue fall 90% to $3.5 million in FY 2025, posting a net loss of $581.6 million. The gene-editing firm burns $345.9 million in cash but holds a strong current ratio of 13.3x. Its CASGEVY therapy for sickle cell disease has gained approval in the US, UK, and EU, with Vertex handling commercialisation under a 60-40 revenue split. Amgen faces pricing pressure from the Inflation Reduction Act and biosimilar competition. CRISPR Therapeutics carries clinical execution risk and ongoing intellectual property disputes.
Amgen and AstraZeneca announced positive results from the phase III DeLLphi-305 study evaluating Amgen's Imdelltra (tarlatamab) combined with AstraZeneca's Imfinzi (durvalumab) as first-line maintenance treatment for extensive-stage small-cell lung cancer (ES-SCLC). The study met its primary endpoint of overall survival and key secondary endpoint of progression-free survival, with no new safety concerns identified. ES-SCLC affects approximately 195,000 people globally. If approved, the combination would compete with Jazz Pharmaceuticals' Zepzelca plus Roche's Tecentriq, which received FDA approval in October 2025. Imdelltra, approved in 2024 for ES-SCLC progression after platinum-based chemotherapy, generated $546 million in global sales during the first half of 2026, up from $215 million in the prior-year period.
Amgen reported FY 2025 revenue of $36.7 billion, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. The biotech serves 17 million patients globally with treatments for heart disease, obesity, and cancer. However, three distributors—McKesson, Cencora, and Cardinal Health—accounted for 77% of gross revenues, creating concentration risk. The company's debt-to-equity ratio stood at 6.3x. Moderna posted FY 2025 revenue of $1.9 billion, down 39.2% as pandemic-related vaccine demand declined. The mRNA specialist reported a net loss of $2.8 billion, resulting in a negative 145.2% net margin due to high research and development costs. The company is pivoting its mRNA platform toward infectious diseases, cancer, and rare conditions whilst expanding through partnerships like its collaboration with Merck.
Amgen trades at $393 per share, representing a trailing multiple of 23.3 times adjusted earnings. The biotech faces declining sales from Prolia and XGEVA, down 33% year-over-year to $1.1 billion in Q2 2026, due to biosimilar competition. Six key growth medicines grew 26% year-over-year, accounting for nearly 70% of Q2 product sales. Analysts forecast the forward multiple at 17.0 times for fiscal 2026 and 16.1 times for 2027. However, consensus assumes expanding profit margins whilst Amgen increases spending. Non-GAAP research spending is set to grow in high single digits for 2026, funding nine Phase III trials for MariTide, its obesity treatment candidate. Management warned of meaningful operating expense increases in Q3 2026. The valuation depends on margin expansion materialising during this investment phase.